surveillance for emerging threats to pregnant …...2018/09/18  · related to dengue, yellow fever,...

70
1 1 CDC PUBLIC HEALTH GRAND ROUNDS Surveillance for Emerging Threats to Pregnant Women and Infants: Data for Action September 18, 2018 Accessible version: https://www.youtube.com/watch?v=0LsGory9nPk

Upload: others

Post on 07-Jul-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

11

CDC PUBLIC HEALTH GRAND ROUNDS

Surveillance for Emerging Threats to Pregnant Women and Infants: Data for Action

September 18, 2018

Accessible version: https://www.youtube.com/watch?v=0LsGory9nPk

Page 2: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

22

Mind the Gap: Missed Opportunities to Prevent Congenital Syphilis

LCDR Ginny Bowen, PhD, MHSU.S. Public Health Service

Epidemiologist, Division of STD PreventionNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention

Page 3: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

33

Congenital Syphilis Cases Are Increasing, as arePrimary and Secondary Syphilis Cases Among Women

*2017 national case report data are preliminary as of June 30, 2018

0

500

1,000

1,500

2,000

2,500

3,000

3,500

0

100

200

300

400

500

600

700

800

900

1000

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017*

Number of P&S Syphilis Cases

Number of Congenital

Syphilis Cases

Congenital syphiliscases

P&S syphilis cases among women aged 15–44 years

Reported Cases of Congenital Syphilis and Primary and Secondary (P&S) Syphilis Among Women of Reproductive Age, U.S., 2007–2017

918

Page 4: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

44

Congenital Syphilis Cases Are Increasing, as arePrimary and Secondary Syphilis Cases Among Women

*2017 national case report data are preliminary as of June 30, 2018

0

500

1,000

1,500

2,000

2,500

3,000

3,500

0

100

200

300

400

500

600

700

800

900

1000

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017*

Number of P&S Syphilis Cases

Number of Congenital

Syphilis Cases

Congenital syphiliscases

P&S syphilis cases among women aged 15–44 years

639

44%

Reported Cases of Congenital Syphilis and Primary and Secondary (P&S) Syphilis Among Women of Reproductive Age, U.S., 2007–2017

918

Page 5: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

55

Congenital Syphilis Cases Are Increasing, as arePrimary and Secondary Syphilis Cases Among Women

*2017 national case report data are preliminary as of June 30, 2018

0

500

1,000

1,500

2,000

2,500

3,000

3,500

0

100

200

300

400

500

600

700

800

900

1000

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017*

Number of P&S Syphilis Cases

Number of Congenital

Syphilis Cases

Congenital syphiliscases

P&S syphilis cases among women aged 15–44 years

176%

334

Reported Cases of Congenital Syphilis and Primary and Secondary (P&S) Syphilis Among Women of Reproductive Age, U.S., 2007–2017

918

Page 6: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

66

Syphilis Is a Complicated Bacterial Infection

Syphilis is caused by the bacteria Treponema pallidum

Signs and symptoms of early syphilis can be difficult to detect

Untreated syphilis then enters a latent phase with no symptoms

Diagnosis is made by medical history, clinical exam, and two blood tests

Early | Late

No symptoms

Primary

StageGenital lesions

within days

to weeks

Secondary

stageRashes, wart-like growths, or

hair loss within weeks to a few months

Latent

phase

Tertiary

stage

Stages of Syphilis

Page 7: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

77

Syphilis Can Be Transmitted in utero If Left Untreated

Infected woman can transmit syphilis to the fetus during pregnancy

● At any stage of syphilis and any trimester of pregnancy

Congenital infection can result in:

● Stillbirth and early infant death

● Infant disorders such as neurologic impairment and bone deformities

Adequately treating syphilis during pregnancy can prevent congenital syphilis Newborn with congenital syphilis rash and

enlarged liver and spleen (marked in black ink)

Page 8: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

88

5 States Make Up 70% of the U.S. Congenital Syphilis Morbidity in 2017

*National CS case report data, preliminary as of June 30, 2018; all states reporting

0 reported CS cases

1–9 reported CS cases

10–29 reported CS cases

≥30 reported CS cases

Page 9: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

99

Prenatal Syphilis Screening Is the Cornerstone of Congenital Syphilis Prevention

www.cdc.gov/nchhstp/pregnancy/screening/clinician-timeline.html

2017 U.S. Preventive Services Task Force affirmation of early screening recommendation: jamanetwork.com/journals/jama/fullarticle/2698933

Kilpatrick SJ, Papile L, & Macones GA. Guidelines for Perinatal Care, 8th Edition. 2017 (6)161-180

Syphilis is curable using injectable, long-acting penicillin

Timely detection and treatment are essential for preventing congenital syphilis and its complications

CDC recommends:

Screening all pregnant women for syphilis

at the first prenatal visit AND

additional screening early in 3rd trimester (≈28 weeks)if high risk for syphilis or living in an area of high morbidity

Page 10: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1010

Understanding Risk Factors May Guide Interventions

Late prenatal care: First visit in the third trimester

(Biswas, 2017)

Risk factors for syphilis among women include:

●Multiple sex partners

●History of incarceration

●Substance use disorders

●History of exchanging sex for drugs/money/housing

●Having a sex partner with multiple sex partners or a history of incarceration

Among pregnant women with syphilis, late or no prenatal care is significantly associated with delivering an infant with congenital syphilis

Page 11: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1111

Four Key Opportunities To Prevent Congenital Syphilis (CS)

Late prenatal care is < 30 days prior to delivery; timely screening is ≥ 30 days prior to delivery

2016 National Case Report Data

Missed Opportunities to Prevent Congenital Syphilis Mothers of Reported Congenital Syphilis Cases (n=628), U.S., 2016

N %

1. Prenatal Care: Received late or no prenatal care and not screened in time 215 34%

2. Screening: Received prenatal care, but not screened in time to treat adequately for CS 51 8%

3. Treatment: Positive initial screening test, but inadequately treated for CS 111 18%

4. Re-screening: Negative initial screening test, but later infected and detected at delivery 101 16%

Other 48 8%

Missing Data: Unknown/inadequate testing or treatment data 102 16%

Total 628 100%

Page 12: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1212

A National “Call to Action” for Syphilis

In April 2017, CDC published a “Syphilis Call to Action” ● Outlines activities to control adult syphilis and prevent

congenital syphilis

Preventing congenital syphilis requires coordination among healthcare providers, public health departments, and pregnant women● Improve pregnancy status verification among women with

syphilis and prospective data collection for pregnant women

● Identify key surveillance gaps and opportunities for collaboration

Page 13: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1313

CDC Pilots Ways to Improve Case Ascertainment and Collection of Risk Factors

In October 2017, CDC awarded $4 million to nine high-morbidity project areas to address congenital syphilis

The goals of the supplemental funding include ● Sustainable improvements to congenital syphilis-related activities

● Strengthened congenital syphilis prevention through prospective information-gathering and interventions

● Strengthened congenital syphilis prevention through retrospective activities to identify opportunities for change

Prospective information to inform interventions

Retrospective review to identify opportunities

Page 14: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1414

Gaps in Current Surveillance System Limit Interpretation and Action

Current methods of surveillance:● Lack timely ascertainment of pregnancy status for women with syphilis

● Lack negative syphilis test results that may allow health departments to monitor rates of screening and re-screening within prenatal care

● Lack linkage between female and congenital syphilis case reports that may allow an understanding of maternal risk factors

● Lack information about syphilis-exposed infants who fail to meet the congenital syphilis case classification, meaning cases cannot be compared to non-cases

● Lack significant detail on fetal syphilis or long-term outcomes for syphilis-exposed infants

Page 15: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1515

Longitudinal Surveillance May Present Opportunities, Including Collaboration with Other Pregnancy-related Conditions

Longitudinal surveillance centered around pregnant women with syphilis may be helpful

● May ensure more complete congenital syphilis case ascertainment

● May allow us to examine additional maternal and fetal factors during pregnancy

● May allow us to follow infants post-partum and document outcomes

Timely entry of pregnant women into longitudinal surveillance may also allow for more real-time health department intervention

Longitudinal surveillance systems may be integrated across diseases

Page 16: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1616

Using Birth Defect Surveillance to Monitor Zika During Pregnancy

Mahsa Yazdy, PhD, MPHDirector, Massachusetts Center for Birth

Defects Research and PreventionMassachusetts Department of Public Health

Page 17: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1717

Zika Virus Infection during Pregnancy

Mosquito-borne flavivirus● Related to dengue, yellow fever, and West Nile

80% asymptomatic, and infection induces lifelong immunity

In 2014–2015, spread to the Americas and the Caribbean● Largest Zika virus outbreak ever recorded

Zika virus infection during pregnancy can cause congenital Zika syndrome● A distinct pattern of birth defects among

fetuses and newborns, including microcephaly and other severe brain and birth defects

Microcephaly Associated with Zika

Page 18: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1818

Two-Pronged Surveillance Captures Impact of Zika

U.S. Zika Pregnancy and Infant Registry

(USZPIR)

Pregnant women and infants with laboratory

evidence of possible Zika virus infection

Zika Birth Defects Surveillance

(ZBDS)

All infants with Zika-related birth defects, with and

without congenital Zika exposure

Surveillance based on OUTCOME of a birth defect associated with Zika

Surveillance based on possible prenatal Zika EXPOSURE

Lead: Birth Defects ProgramLead: State Lab

Page 19: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

1919

U.S. Zika Pregnancy and Infant Registry (USZPIR)

Lead: Bureau of Infectious Disease and Laboratory Sciences

Priority: Testing pregnant women and providing education

Data collected on maternal health history, pregnancy exposures, neonatal outcomes, and infants followed through age 2

In Massachusetts, all infections travel related● 174 pregnant women reported, 169 infants being followed

Collaboration with Birth Defects Monitoring Program● Complete maternal and neonate assessment forms

● Notify program of pregnant women with positive test

● Notify program if birth defect identified during follow-up USZPIR

Page 20: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2020

Zika Birth Defects Surveillance (ZBDS)

WIC: Special Supplemental Nutrition Program for Women, Infants, and Children

Lead: Birth Defects Monitoring Program

Priority: Rapid surveillance of infants with Zika associated birth defect, regardless of Zika exposure

Inform affected families of MCH services (e.g., early intervention, WIC)

In Massachusetts● 690 infants and fetus identified (1/1/16–5/31/18)

Collaboration with state lab● Notify lab if mention of Zika exposure in medical records

● Cross-check with lab to see if cases are in USZPIR, or if cases had negative Zika tests ZBDS

Page 21: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2121

Massachusetts Birth Defects Monitoring Program is anActive, Population-based Birth Defects Surveillance

Receive reports of cases

Abstractors review hospital records

Abstract info on cases

Clinical review and classification of cases

Confirmed cases included in birth defects registry

Data available for surveillance

and research

Data sourcesBirthing and non-birthing hospitalsPrenatal reporters Commercial laboratoriesSelected outpatient recordsEmergency departmentsPathology departmentsVital records

(i.e., birth, death, and fetal death certificates)

Page 22: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2222

Massachusetts Birth Defects Monitoring Program is anActive, Population-based Birth Defects Surveillance

EMR: Electronic medical records

Receive reports of cases

Abstractors review hospital records

Abstract info on cases

Clinical review and classification of cases

Confirmed cases included in birth defects registry

Data available for surveillance

and researchRemote access to

EMRs

Prioritize ZBDS cases

Page 23: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2323

Increased Timeliness of Zika Birth Defects Surveillance (ZBDS)

Prioritize abstraction of ZBDS cases● Push Zika related birth defects

cases to the top of abstraction list

Remote access to EMR● 18 hospitals with remote access

6 hospitals pending

● Access at 4 tertiary hospitals accounted for 35% of abstractions

0

20

40

60

80

100

Mar-16 May-16 Jul-16 Sep-16 Nov-16 Jan-17 Mar-17 May-17 Jul-17

Me

an N

um

be

r o

f D

ays

Month of Ascertainment

Mean Days Between Ascertainment & Abstraction,Massachusetts ZBDS

≈50% reduction

EMR: Electronic medical records

Page 24: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2424

Data Uses: Establishing the Baseline Prevalence of Birth Defects

Honein MA, Dawson AL, & Petersen EE. JAMA 2017; 317(1): 59–68

From USZPIRAmong completed pregnancies in the U.S. with lab evidence of possible Zika infection● 6% fetuses or infants had Zika-

associated birth defects ● In symptomatic and asymptomatic

women, similar proportion with birth defects (≈6%)

● Among women with infection in the 1st trimester, Zika-associated birth defects reported in 11%

Page 25: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2525

Data Uses: Establishing the Baseline Prevalence of Birth Defects

Honein MA, Dawson AL, & Petersen EE. JAMA 2017; 317(1): 59–68 Cragan JD, Mai CT, & Petersen EE. MMWR 2017; 66(8): 219–222

From USZPIRAmong completed pregnancies in the U.S. with lab evidence of possible Zika infection● 6% fetuses or infants had Zika-

associated birth defects ● In symptomatic and asymptomatic

women, similar proportion with birth defects (≈6%)

● Among women with infection in the 1st trimester, Zika-associated birth defects reported in 11%

From Established Birth Defects Surveillance Systems● Baseline prevalence pre-Zika:

≈3 per 1000 live births● Prevalence for pregnancies with Zika

exposure: ≈60 per 1000 live births 20-fold increase in Zika-related

birth defects 33-fold increase for brain abnormalities

or microcephaly

● Demonstrate the importance of birth defects surveillance

Page 26: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2626

Update on Zika Surveillance in Massachusetts

MA fifth largest Puerto Rican population in U.S.● Families relocating from hurricane-impacted areas

Currently assessing needs and gaps

Ongoing goal● Connect families to available maternal child

health services

● Identify families with an infant affected by Zika

● Notify state lab of potential USZPIR-eligible infant

Page 27: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2727

Challenges

USZPIR: U.S. Zika Pregnancy and Infant Registry

Establishing standard case definition ● Review cases to understand common possible phenotypes

● In Massachusetts Some Zika-associated conditions not previously in surveillance (e.g., intracranial calcifications)

Work with newborn hearing screening to identify infants with congenital deafness

Communication between healthcare providers

Infants in USZPIR lost to follow-up 34% lost within first year of life

Long-term outcomes not well understood

Page 28: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2828

Successes

Early collaboration resulted in a more robust response to Zika

Massachusetts was the first state to send Pregnancy Registry data and among the first group to send Birth Defects Surveillance data to CDC

Improved data quality● e.g., Birth Defects Program abstraction helps link State Lab to pediatricians for

later follow-up

Jointly organized other activities● e.g., outreach campaign, webinar for providers, and

Zika advisory committee

Connecting to other programs● e.g., working on linking Pregnancy Registry and Birth Defects

Surveillance data to Early Intervention

Page 29: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

2929

A New System for Surveillance and Collaborations Models the Future

Provided a model for response to future infectious outbreaks related to birth defects

Facilitated improvements● In our surveillance system

● In inter-bureau collaboration that will be of use well beyond the Zika epidemic

Provided data to evaluate the potential impact of Zika infection during pregnancy

Page 30: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

3030

Adapting Zika Birth Defects Surveillance to Rapidly MonitorNeonatal Abstinence Syndrome

Sharon Watkins, PhDState Epidemiologist and

Bureau DirectorBureau of Epidemiology

Pennsylvania Department of Health

Page 31: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

3131

Overview

Neonatal Abstinence Syndrome: Newborn withdrawal from prenatal substance exposure

Signs and Symptoms of Neonatal Abstinence Syndrome Tremors SeizuresIrritability High-pitched cryingIncreased muscle tone Hyperactive deep tendon reflexesPoor feeding Gastrointestinal tract dysfunction

How we, as a state with no birth defects surveillance prior to 2016, used Zika Birth Defects Surveillance resources and lessons learned to rapidly respond to an emerging threat—Neonatal Abstinence Syndrome

Page 32: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

3232

Birth Defects Surveillance Prior to CDC Funding for Zika Birth Defects Surveillance (ZBDS)

www.cdc.gov/nchs/data/nvsr/nvsr66/nvsr66_01.pdf

3,978,497 U.S. live births (2015)

44 states with some type of birth defects surveillance program● 3,712,704 live births covered

Six states without a birth defects surveillance program (2015)● Pennsylvania was the largest

States Without Birth Defects Surveillance Program

2015 Live Births

Pennsylvania 141,047

Alabama 59,657

Idaho 22,827

Montana 12,583

South Dakota 12,336

Wyoming 7,765

Page 33: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

3333

Pennsylvania Challenges for Birth Defects Surveillance

Legal challenges: No specific legislative authority to make direct requests to hospitals or physicians for cases

Birth certificates: Limited source for birth defects case finding

Hospital discharge data (outsourced): Provides de-identified data● Problematic for following transferred infants

● No history of state surveillance exists to evaluate validity of coding if case verification is not performed

Other sources?● Voluntary reporting

● Network building

Page 34: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

34

Zika Birth Defects Surveillance Process

Legal authority gained in 2016● After review, outcomes, such as possible birth defects from a reportable

infectious disease, were reportable

Surveillance method: Passive + Active● PASSIVE

1. Contact birthing facilities (ICD-10 discharge codes)

2. Process facility-provided case lists to remove non-cases

3. Send final case list for review to facility

● ACTIVE4. Review medical records for case verification and abstraction

5. Record data in REDCap Cloud electronic database

Page 35: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

35

Progress after CDC Zika Birth Defect Surveillance funding began August 2016:

April 2017

New team of three people

in place

September 2017

Received first facility-provided list

of potential cases for review

October 2017

Uploaded first abstracted cases

to CDC portal

Birth Defects Surveillance—Initial Activities Timeline

Page 36: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

36

Three months later… January 2018, the governor

declared 90-day state of emergency for the

opioid epidemic and asks for

● Neonatal Abstinence Syndrome: Rapid case ascertainment

Neonatal Abstinence Syndrome Surveillance Background

Page 37: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

3737

Neonatal Abstinence Syndrome (NAS) in Pennsylvania

2017 estimated costs based on 2013 average Medicaid payments

Pennsylvania Health Care Cost Containment Council. (PHCCCC) (2018, March). Hospitalizations for Newborns with Neonatal Abstinence Syndrome.

Increasing NAS-related hospitalstays per 1,000 newborn stays

Hospital inpatient data report from PHCCCC:● Greater than 1,000 percent

increase in newborn stays

● Greater than $14 million in estimated costs for NAS-related stays in 2017

Page 38: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

38

Short Term Options

Consider options for short/near term data collection:● PA-NEDSS

● Paper-based report form

● Web-based system

X Web-based for streamlined data collection

PA-NEDSS: Pennsylvania’s version of National Electronic Disease Surveillance System

Page 39: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

39

ZBDS: Zika Birth Defects Surveillance

NAS: Neonatal Abstinence Syndrome

Leveraging Knowledge Gained from ZBDS

BIRTH DEFECTS SURVEILLANCE

Birthing Facilities

Birth Records Data

REDCap Cloud Database

NAS REPORTING

Birthing Facilities

Birth Records Data

REDCap Cloud Database

Birthing Facilities: Use ZBDS contacts, annual live births data, plus strategy of prioritizing largest birth facilities

Birth Records Data: Apply ZBDS knowledge of data available in infant’s medical record

REDCap Cloud Database: Leverage extensive validation performed during ZBDS setup● Experience with functional capability

● Completed user acceptance testing DATA PREPAREDNESS

Page 40: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

40

Creating A Case Report Form

Perform literature review

Identify potential users

Consider data available at time of entry

Create defined response sets

Key: Use ‘one-page’ approach● Visually shortened with skip-patterns and dropdowns

● Consider variables for collection

● Balance between:1. Robust clinical data

2. One page template

Page 41: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

4141

Neonatal Abstinence Syndrome (NAS) Data Collection

Case definition: NAS diagnosed in an infant during the neonatal period (birth to 28 days) who has symptoms of withdrawal from prenatal exposure to opiate drugs either via

prescription, medical therapy, or illegal use.

Rapid case ascertainment began in less than 1 month

1/10/2018Declaration of

Emergency

1/11/2018Preparation

(Facilities, CRF)

1/24/2018Green light to proceed

1/26/2018Electronic survey

completed

2/8/2018Live survey distribution

to 93 facilities

1/1/2018 2/15/2018

Page 42: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

42

State of emergency has been renewed twice, each time for an additional 90-day period.

Two facilities added to original list, totaling 95.

NAS Data Collection: Number of Cases

Within two days, 18 cases were reported from six facilities

1853

330474

625758

982

11531308

1419

0

200

400

600

800

1000

1200

1400

1600

0 1 2 3 4 5 6 7 8

Nu

mb

er

of

Cas

es

Number of Months Since Data Collection Started

Total NAS Cases Reported

Page 43: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

43

State of emergency has been renewed twice, each time for an additional 90-day period.

Two facilities added to original list, totaling 95.

NAS Data Collection: Number of Facilities

6

24

6066

73 74 76 79 79 80(84%)

0

10

20

30

40

50

60

70

80

90

0 1 2 3 4 5 6 7 8

Nu

me

r o

f Fa

cilit

ies

Number of Months Since Data Collection Started

Total Facilities Reporting Cases ThatMeet Case Definition

Page 44: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

4444

Neonatal Abstinence Syndrome (NAS) Data Summary

The PADOH specifically disclaims responsibility for any analyses, interpretations, or conclusions.*Values represent combined data from years 2012-2016.

NAS (2018) PA 2016 live births

Total Responses n % n1 %

Total NAS Cases 1201 1201 (100%)

Maternal

Race Identified as White 1201 1029 86 97,939 70

Prenatal Care Any known prenatal care 1171 1008 86 137,227 98

Payment Source Principle source = Medicaid 1201 984 82 225,034* 32*

Infant

Birth Weight Less than 2500 grams at birth 1187 232 20 11,375 8

Gestational Age Less than 37 weeks 1187 184 15 12,951 9

Level of Care Received care in a NICU 1201 564 47

SymptomsDisplayed 3 or more NAS symptoms

1201 1123 94

Page 45: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

4545

NAS Data Summary—Laboratory Testing

n %

Total Number of NAS Cases Reported 1201 100

Laboratory Evidence of Exposure in Infant (Missing=30) 1171 (100%)

Test Results

Tested positive 780 67

Tested negative 146 12

Pending 130 11

Not Tested 115 10

Among Total Number of Infants Testing Positive 780* (100%)

Type of Opioid Detected

Some form of opioids 663 85

Medications used to treat substance use (methadone, buprenorphine)

522 67

Oxycodone, fentanyl, other opiates or synthetic opioids 180 23

*Categories not mutually exclusive

“Medications used to treat substance use” category may also include illicit use of these drugs

Page 46: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

46

NAS Data Summary—Infant Treatment

Categories not mutually exclusive

Infant Treatment n %

Total Number of NAS Cases Reported 1201 100

No treatment 359 30

Morphine 531 44

Nonpharmacologic treatment 311 26

Other pharmacologic treatment 131 11

Page 47: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

47

NAS Data Collection

Other Initiatives● Distributed guidance with authority to report, case definition, and

exclusion criteria—in one notification

● Collaborated with The Hospital & Healthsystem Association of Pennsylvania (HAP) advocacy organization

● Created ‘Frequently Asked Questions’ document

● Included ‘Comments or Questions’ box within survey Aid data collection and communication

Page 48: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

48

Challenges

Limited Resources for Continuous

Facility Outreach

– No nationally standardized case definition for public health surveillance!

– ‘Reporting' case definition vs. within-facility diagnosis criteria

– Reporting timeframe

– Understanding barriers for non-reporters

– Maintaining continuous facility participation

Case Definition

Little Time for Reporter Education

Page 49: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

49

Successes Leading to Data Preparedness

Built Capacity

Maintained State Momentum

Provided Precedent

– Leveraged infrastructure and the experience gainedfrom the one-time supplemental Zika funding

– During declaration of emergency, collected largeamounts of clean data in a short period

– Proved a viable method for collecting data on emerging threats

Page 50: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

50

CDC Epi-Aid Assistance

● Survey facilities to assess barriers to reporting

● Identify varying case definitions and barriers to diagnosis

● Evaluate data validity

Next Steps for Pennsylvania

Data Preparedness Model:

Rapid demographic and clinical data leads to detailed next steps

Page 51: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

51

Next Steps for Pennsylvania

Make NAS reportable beyond the declaration

Consider adding NAS to newborn screening module

Discuss with partners:● Department of Human Services: Office of Children, Youth and Families

● Department of Health: Bureau of Family Health Engaged in survey that will evaluate facilities’ current testing and diagnosis methods, and current

policies and procedures

Collaborating on public health actions and guidance, including the development of plans of safe care in compliance with the Child Abuse Prevention and Treatment Act (CAPTA)

Page 52: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5252

Emerging Health Threats: How Surveillance Can Inform Clinical Practice

Dana Meaney-Delman, MD, MPHActing Branch Chief, Prevention Research and Translation Branch

Division of Congenital and Developmental Disorders

National Center on Birth Defects and Developmental Disabilities, CDC

Page 53: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5353

Protecting Pregnant Women and Infants: A Personal Story

Clinical Practice

Public Health SurveillanceClinical Guidance

Page 54: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5454

Maternal Outcomes• Pregnancy loss• Maternal morbidity• Maternal mortality• Lack of access to care

Infant Outcomes• Birth defects• Preterm birth• Small for gestational age/low birth weight• Neonatal complications (e.g., NAS)• Infant morbidity and mortality

Child Outcomes• Cognitive impairment• Motor development• Developmental delays• Behavioral issues• Educational attainment

Outcomes Related to Exposures during Pregnancy

Surveillance data can identify outcomes

associated with exposures during

pregnancy

Page 55: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5555

Recent Public Health Emergencies

2009 H1N1Influenza

2014 Ebola

What did we learn?

Pregnant women and infants may experience severe outcomes

Rapid data collection can inform emergency response activities and new guidance

Healthcare providers request guidance on infection control, prevention and treatment of emerging diseases

2016 Zika

Page 56: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

56

Lessons Learned: H1N1 Influenza

Increased mortality● 5% of all deaths were among pregnant women, who represent 1% of

general population

Importance of treating pregnant women with influenzaantiviral medications

Challenges with vaccine acceptance

Need for up-to-date scientific information during an evolving outbreak situation● Pregnancy flu-line: Surveillance and clinical hotline

Page 57: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5757

Lessons Learned: Ebola

High rates of pregnancy loss, maternal and neonatal death

Unclear if women disproportionately affected or higher rates of maternal mortality

OB wards served as points of transmission● Viral shedding in amniotic fluid and placenta

Recommendations needed for labor and delivery setting

Page 58: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5858

Lessons Learned: Zika Virus

Zika causes serious brain abnormalities

Pattern of birth defects:

congenital Zika syndrome

5-10% risk of birth defects

from congenital infection

Zika infection during any trimester

associated with birth defects

Page 59: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

5959

Zika Pregnancy and Infant Surveillance: Data for Action

U.S. Zika Pregnancy and Infant Registry

Conception

Zika Virus Infection

Delivery Infancy Childhood

1

Page 60: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6060

Zika Pregnancy and Infant Surveillance: Data for Action

U.S. Zika Pregnancy and Infant Registry

Birth Defects Surveillance

Conception

Zika Virus Infection

Delivery Infancy Childhood

Possible Zika Exposure

Conception Delivery Infancy

Referral to services

1

2

Page 61: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6161

Zika Pregnancy and Infant Surveillance: Data for Action

U.S. Zika Pregnancy and Infant Registry

Birth Defects Surveillance

Conception

Zika Virus Infection

Delivery Infancy Childhood

Possible Zika Exposure

Conception Delivery Infancy

Referral to services

1

2

Health Department Surge Capacity 3

U.S. Zika Pregnancy Hotline 4

Page 62: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6262

Benefits of Surveillance Data

Data collected on Zika during

pregnancy

National

State

Community

Individual

Informed all levels

Informed clinical guidance for care and management of pregnant women and infants with Zika

Allowed for targeted outreach to healthcare providers serving most impacted communities

Identified affected families and connected them to local medical and social services

Facilitated Zika virus testing for pregnant women and infants and the interpretation of results

Examples

Page 63: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6363

Applying Lessons Learned to Other Pregnancy Exposures

Maternal Outcomes• Pregnancy loss• Maternal morbidity• Maternal mortality• Prolonged hospital stay• Lack of access to care

Page 64: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6464

Applying Lessons Learned to Other Pregnancy Exposures

Infant Outcomes• Birth defects?• Preterm birth• Small for gestational age/low birth weight• Neonatal complications (e.g., NAS)• Prolonged hospital stay• Infant morbidity and mortality

Page 65: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6565

Applying Lessons Learned to Other Pregnancy Exposures

Child Outcomes• Cognitive impairment• Motor development• Developmental delays• Behavioral issues• Educational attainment• Family dynamics

Page 66: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6666

Surveillance for Emerging Threats NETwork (SETNET)

Monitor mothers and children with exposures during pregnancy1

Pregnancy and Infant

Surveillance System

to monitor health threats

Provide health department surge capacity 3

Adapt birth defects surveillance to rapidly monitor associated outcomes2

Provide ongoing assistance to healthcare providers 4

Page 67: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6767

Common Themes: Common Needs

Longitudinal surveillance of mother and infant dyad

Routine capture of pregnancy status

Collection of real-world, timely data to inform the best care for mothers and infants

Standard case definitions

Access to and linkage of multiple data sources

Outreach and education

Page 68: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6868

Common Themes: Common Challenges

Inconsistent case definitions hindercomparing and combining data

Identifying exposed pregnant women

Lost to follow up

Unknown long-term outcomes ● How will children exposed prenatally thrive

as they grow?

● What services and support will they need?

Page 69: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

6969

Pregnancy and Infant Surveillance: Data to Action

Clinical practice

Public Health Surveillance

Clinical Guidance

Page 70: Surveillance for Emerging Threats to Pregnant …...2018/09/18  · Related to dengue, yellow fever, and West Nile 80% asymptomatic, and infection induces lifelong immunity In 2014–2015,

7070

A Call to Action

A sustained and consistent approach to surveillance for pregnant women and infants

can ensure public health and clinical communities:

• Act early to protect mothers and babies

• Identify maternal risks (e.g., morbidity and mortality) and childhood risks (e.g., birth defects, health problems, developmental delays, and functional disabilities)

• Inform prevention strategies and clinical management

• Link affected families to medical and social services